title: Identification of pharmaceutical impurities in formulated dosage forms.
abstract: Structure elucidation of pharmaceutical impurities is an important part of the drug product development process. Impurities can have unwanted pharmacological or toxicological effects that seriously impact product quality and patient safety. This review focuses on current analytical strategies for chemical and structural identification of pharmaceutical impurities. Potential sources and mechanisms of impurity formation are discussed for both drug substance and drug product applications. The utility of liquid chromatography-mass spectrometry (LC/MS) for providing structure-rich information is highlighted throughout this review. Other hyphenated analytical techniques including LC/nuclear magnetic resonance, gas chromatography/MS, and size-exclusion chromatography/chemiluminescent nitrogen detectors are also discussed, as LC/MS alone sometimes cannot reveal or confirm the final structures as required during dosage form development.
authors.affiliation: Pharmaceutical and Analytical Development, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936. charles.pan@novartis.com.
authors.forename: Changkang
authors.initials: C
authors.lastname: Pan
authors.forename: Frances
authors.initials: F
authors.lastname: Liu
authors.forename: Michael
authors.initials: M
authors.lastname: Motto
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D004355:Drug Stability; D009682:Magnetic Resonance Spectroscopy / Q000379:methods; D013058:Mass Spectrometry / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000737:chemistry
chemical_list: D004364:Pharmaceutical Preparations
keywords: chemical stability; chromatography; drug degradation; excipients; formulation; mass spectrometry; pharmaceutical impurity; solid dosage form